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Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Preparing anonymisation reports in general and for an orphan drug in particular - Volume 27, Issue

In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…

News from the EMA - Volume 32, Issue

This section offers a selection from recent news items from the EMA. Medical Writing. 2023;32(2)86–91.

Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia - Volume 22, Issue

The Faculty of Medicine in Belgrade, Serbia, has a long tradition of learning and teaching English for Medical Academic Purposes (EMAP). EMAP is considered extremely important for our medical students' academic and professional life. Our EMAP…

The Light Stuff - Volume 22, Issue

The medical profession has a well-deserved reputation for atrocious handwriting, which has undoubtedly led to many mishaps in patient care. Sometimes, however, problems in interpreting doctor's writing, as those of us who have worked on publications…

In the Bookstores - Volume 24, Issue

Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages. Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…

Medical Devices - Volume 29, Issue

May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…

Veterinary Medical Writing - Volume 29, Issue

All three articles in this Veterinary Medical Writing section were written when COVID-19 was not classified as a pandemic. Yet all three articles tie into the current narrative of regulation in veterinary medicine and the need for communication…

Medicinal products and medical devices in clinical trials conduct and disclosure - Volume 28, Issue

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…

The Webscout - Volume 26, Issue

Medical devices range from things as simple as an injection needle to implantable pacemakers and MRI imaging devices. A video by the WHO (http://t1p.de/WHOVideo) gives you an impression of the variety of medical devices and their importance for…

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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